Intracerebral HemorrhagePhase 1TNK in ICHNCT06696131
Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH)
A Phase 1 study testing TNK in people with Intracerebral Hemorrhage and Intracranial Hemorrhages, run by Gaurav Gupta, MD.
Trial summary
The overall purpose of this study is to look at the safety and effectiveness of administering Tenecteplase (TNK) into the brain bleed (hematoma) instead of another clot-dissolving drug known as recombinant tissue plasminogen activator (rtPA), which is the current standard practice. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage, Intracranial Hemorrhages, Hemorrhagic Strokes
- What is being tested?
- TNK
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2026to 31 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient/legally authorized representative has signed the Informed Consent Form.
- Ability to comply with the study protocol, in the investigator's judgment.
- Patients 18 to 80 years of age with an ICH had occurred within 24 hours before admission.
- Spontaneous supratentorial (basal ganglia, thalamus, lobar) ICH ≥30 mL measured utilizing the ABC/2 method.
- Subjects with a GCS score of 5-14.
- NIHSS ≥6.
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- Stability CT scan done at least 6 hours after baseline CT showing clot stability (growth <5 mL as measured by ABC/2 method). If the hematoma volume measured on the stability CT scan increases by 5 mL or more, a second stability CT scan will be performed 12 hours later.
- Sustained systolic blood pressure (SBP) <180 mm Hg for six hours recorded closest to the time of drug administration.
- Symptoms must be present less than 24 hours prior to baseline CT scan.
- Baseline Rankin score of 0 or 1.
Who cannot join
- Presence of infratentorial parenchymal bleeding.
- Presence of a hemorrhage extending to the midbrain.
- An unknown time of onset or the symptoms onset more than 24 hours prior to admission.
- Pregnancy.
- Inability to obtain written informed consent from subject or legal representative.
- Sustained SBP >180 mm Hg for six hours recorded closest to the time of drug administration.
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- Age <18 and >80 years.
- Radiological evidence of arterio-venous malformation, aneurysm, amyloid angiopathy, Moyamoya disease, hemorrhagic conversion of an ischemic stroke, recurrent hemorrhage in the same location within the past 365 year or unstable mass as a source for the ICH.
- Evidence of coagulopathy (international normalized ratio >1.3; platelet count <100 ,000 or platelet dysfunction P2Y-12 >250) or known clotting disorder.
- Bilateral fixed, dilated pupils indicating irreversible impaired brain stem function with GCS ≤4.
- Patients with severe ICH and IVH who require an external ventricular drain (EVD) placement for cerebrospinal fluid (CSF) diversion or separate intraventricular thrombolysis.
- Inability to maintain INR less than 1.3.
- Use of anticoagulants prior to symptom onset and subjects requiring long-term anticoagulants (the reversal is permitted if the patient can tolerate the short-term risk of reversal).
- Use of Dabigatran, Apixaban, and/or Rivaroxaban (or a similar medication from the similar medication class) prior to symptom onset.
- Internal bleeding (GI, renal, respiratory etc).
- Mechanical heart valve (Bioprosthetic heart valve is permitted).
- Known risk for embolization, including history of left heart thrombus, mitral stenosis with atrial fibrillation, acute pericarditis, or subacute bacterial endocarditis (atrial fibrillation without mitral stenosis is permitted).
- Allergy or sensitivity to TNKase.
- Participation in a concurrent clinical trial.
- Serious illness (advanced stage which can interfere with the outcome).
- The patient is unstable and would not benefit from a surgical intervention.
- GCS score of 3-4 and 15 (to ensure patient safety and study feasibility).
- Historical mRS score of 2-6 (at admission).
- Symptomatic tract hemorrhage or a tract hemorrhage more than 5 mm.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The overall purpose of this study is to look at the safety and effectiveness of administering Tenecteplase (TNK) into the brain bleed (hematoma) instead of another clot-dissolving drug known as recombinant tissue plasminogen activator (rtPA), which is the current standard practice. Clot dissolving (Fibrinolytic) drugs work to break down blood clots and have been found to improve health outcomes when applied directly into the hematoma within the brain. Patients who take part in this study will undergo the same surgical procedure that would normally be performed to treat them, but with the exception of TNK not rtPA.
- Being tested
- TNK
- Medical subject headings
- Cerebral Hemorrhage, Intracranial Hemorrhages, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNKDrug
TNK will be delivered into the site of the intracerebral hemorrhage via a brain catheter.
| Study group | Role | What they receive |
|---|---|---|
| TNK | Experimental | Participants would be given TNK through a brain catheter to dissolve an intracerebral blood clot after a hemorrhage. Receives: Drug: TNK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessment
To assess the safety of 0.25 mg TNKase (single dose) administered directly into the hematoma via a soft brain catheter in patients with ICH.
Measured: From treatment until follow-up date (+/- 30 days)
Adverse Event Evaluation
To evaluate the incidence and severity of adverse events, such as rehemorrhage, infection, mortality at 30 days following the administration of TNKase.
Measured: From treatment until follow-up date (+/- 30 days)
Secondary outcomes (1)
Radiological Assessment of the Hematoma Resolution
Using radiological imaging, we will assess the resolution of the hematoma from the brain with the end of treatment volume goal as 15 ml and compare these findings to baseline imaging obtained prior to TNKase administration
Measured: From treatment until follow-up date (+/- 30 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start15 Sep 2026 (estimated)
- Primary completion15 Jan 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaurav Gupta, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor-investigator, Gaurav Gupta, MD, Rutgers, The State University of New Jersey
- Investigators
- Gaurav Gupta, MD, Principal investigator, Rutgers University, RWJ Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696131
- Sponsor's protocol ID
- Pro2024001604
- Acronym
- TNK in ICH
- Status last verified
- Apr 2026
- First submitted
- 14 Nov 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenecteplase (TNK) in the Treatment of Intracerebral Hemorrhage (ICH)
- ClinicalTrials.gov ID
- NCT06696131
- Acronym / sponsor ID
- TNK in ICH / Pro2024001604
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Gaurav Gupta, MDUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 20 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this study is to look at the safety and effectiveness of administering Tenecteplase (TNK) into the brain bleed (hematoma) instead of another clot-dissolving drug known as recombinant tissue plasminogen activator (rtPA), which is the current standard practice. Clot dissolving (Fibrinolytic) drugs work to break down blood clots and have been found to improve health outcomes when applied directly into the hematoma within the brain. Patients who take part in this study will undergo the same surgical procedure that would normally be performed to treat them, but with the exception of TNK not rtPA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TNK | Experimental | Drug: TNKParticipants would be given TNK through a brain catheter to dissolve an intracerebral blood clot after a hemorrhage. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient/legally authorized representative has signed the Informed Consent Form.
- Ability to comply with the study protocol, in the investigator's judgment.
- Patients 18 to 80 years of age with an ICH had occurred within 24 hours before admission.
- Spontaneous supratentorial (basal ganglia, thalamus, lobar) ICH ≥30 mL measured utilizing the ABC/2 method.
- Subjects with a GCS score of 5-14.
Key exclusion criteria (24 listed)
- Presence of infratentorial parenchymal bleeding.
- Presence of a hemorrhage extending to the midbrain.
- An unknown time of onset or the symptoms onset more than 24 hours prior to admission.
- Pregnancy.
- Inability to obtain written informed consent from subject or legal representative.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNKTNK will be delivered into the site of the intracerebral hemorrhage via a brain catheter. | Drug | TNK |
Primary outcome
Safety Assessment
Time frame: From treatment until follow-up date (+/- 30 days)
To assess the safety of 0.25 mg TNKase (single dose) administered directly into the hematoma via a soft brain catheter in patients with ICH.
Adverse Event Evaluation
Time frame: From treatment until follow-up date (+/- 30 days)
To evaluate the incidence and severity of adverse events, such as rehemorrhage, infection, mortality at 30 days following the administration of TNKase.
1 secondary outcome
Radiological Assessment of the Hematoma Resolution
Time frame: From treatment until follow-up date (+/- 30 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gaurav Gupta, MD principal investigator
Rutgers University, RWJ Medical School
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TNK in people with Intracerebral Hemorrhage and Intracranial Hemorrhages, run by Gaurav Gupta, MD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine N Yohn, Ph D (908-328-4210, cy253@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Assessment (time frame: From treatment until follow-up date (+/- 30 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.